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Session 11 Track 4: New Trends and Challenges in Combination Products, Companion Diagnostics, and Digital Health Technologies
Session Chair(s)
Vahe Ghahraman, PhD
Senior Director, Global Regulatory Operations Head
Apellis Pharmaceuticals, Inc. , United States
This session focuses on challenges and opportunities related to the development and commercialization of combination products and companion diagnostics from both the regulatory and industry perspectives. It also covers the impact of the recent advancements in digital health technologies for improving healthcare outcomes and patient experiences. Furthermore, it offers considerations and ways to manage the complex challenges created by myriad of new regulatory policies and ensure compliance with safe and efficacious deployment of such technologies.
Learning Objective : - Evaluate impacts of combination products on regulatory affairs' ways of working
- Share challenges in dealing with Health Authority regulatory processes and pathways related to development and commercialization of combination products and best practices to manage them
- Explore the considerations and challenges associated with operationalizing regulatory policy assessments for digital health
Speaker(s)
The Growing Impact of Combination Products and Companion Diagnostics – A Regulatory Perspective
Kavita A. Vyas
FDA, United States
Review Chemist, OD, CBER
The Growing Impact of Combination Products and Companion Diagnostics – An Industry Perspective
Brian Williams
KPMG, United States
Advisory Managing Director, Life Sciences
Considerations and Challenges of Operationalizing Regulatory Policy Assessments for Digital Health
Stephen Philipp
Merck, United States
Associate Director Regulatory Digital Health / Policy Execution
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